Healthy volunteers
Conditions
Interventions
Subjects receive 3 tablets/day containing a total of 30 mg of 5-aminolevulinic acid phosphate and 34.5 mg of sodium ferrous citrate (3.6 mg as Fe) for 8 weeks.
Subjects receive 3 placebo tablets/day c
Sponsors
Hiroshima University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Healthy with physical fatigue on a day-to-day basis (VAS>=40 mm at baseline) 2) POMS2-T score of Fatigue-Inertia >=50, and POMS2-T score of Vigor-Activity<=60 at baseline
Exclusion criteria
Exclusion criteria: 1) Taking medicines for chronic disease 2) Taking functional food that may affect the trial 3) Participation in any clinical trial within 90 days of the commencement of the trial 4) In pregnancy or nursing a child 5) Judged as ineligible by clinical investigators
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change of VAS (Visual Analogue Scale) for overall fatigue from baseline (Time frame: Baseline, week 0, week 4, and week 8) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) Change of VAS for fatigue due to work, work efficiency, and fatigue when one wakes up, from baseline (Time frame: Baseline, week 0, week 4, and week 8) 2) Change of POMS2 (Profile of Mood States 2nd Edition-Adult)-T scores of Fatigue-Inertia and Vigor-Activity from baseline (Time frame: Baseline, week 0, week 4, and week 8) | — |
Countries
Japan
Contacts
Public ContactFumiko Higashikawa
Graduate School of Biomedical and Health Sciences, Hiroshima University Department of Probiotic Science for Preventive Medicine
Outcome results
None listed